OD vs. TID Dosing With Mesalazine Granules in Active Ulcerative Colitis

Dr. Falk Pharma

Status and phase

Completed

Phase 3

Conditions

Ulcerative Colitis

Treatments

Drug: mesalazine

Study type

Interventional

Funder types

Industry

Identifiers

NCT00449722

2004-001216-31

SAG-26/UCA

Details and patient eligibility

About

To proof the therapeutic equivalence of once daily (OD) versus three times daily (TID) dosing of total 3.0 g mesalazine granules in patients with active ulcerative colitis

Sex

All

Ages

18 to 75 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria (main):

Active ulcerative colitis except proctitis, i.e. inflammation minimal 15cm ab ano, confirmed by endoscopy and histology
Established or new diagnosis
Disease activity at baseline: Clinical Activity Index (CAI) >4 and Endoscopic Index (EI) >= 4

Exclusion Criteria (main):

Crohn's disease
Toxic megacolon
Present or past colorectal cancer
Symptomatic gastrointestinal disease
Serious secondary disease(s)
Baseline stool positive for germs causing bowel disease
Immunosuppressants within 3 months and/or corticosteroids within 1 month prior to baseline
Current relapse occurred under maintenance treatment with >2g/day mesalazine
Serum creatinine >= 1.2x upper limit of normal (ULN) and creatinine clearance < 60 ml/min per 1.73 m2
Serum transaminase (ALT and/or AST), and/or alkaline phosphatase >= 2x ULN